(22 days)
Not Found
No
The summary describes implantable neurostimulation leads and their intended use for pain management. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for alleviating chronic intractable pain, which is a therapeutic purpose.
No
The devices are indicated for Spinal Cord Stimulation and Peripheral Nerve Stimulation to aid in the management of chronic intractable pain, meaning they are therapeutic devices that deliver stimulation, not diagnostic devices that identify or measure a condition.
No
The device description explicitly states "Quadripolar implantable neurostimulation surgical leads with in-line connector," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are used for "Spinal Cord Stimulation" and "Peripheral Nerve Stimulation" to manage chronic intractable pain. This involves directly stimulating nerves within the body.
- Device Description: The device is described as "Quadripolar implantable neurostimulation surgical leads." This is a physical implant used for electrical stimulation.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of samples or analysis of biological materials.
Therefore, the function and description of this device align with an implantable neurostimulator, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Resume II Model 3587A and Resume TL Model 3986A are indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs. They are also indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.
On-Point Model 3987A is indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.
SymMix Model 3982A is indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs.
Product codes (comma separated list FDA assigned to the subject device)
GZB, GZF
Device Description
Quadripolar implantable neurostimulation surgical leads with in-line connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal Cord, Peripheral Nerve
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data that supports the safety and effectiveness of the ILS leads for neurostimulation are included in this 510(k) premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).
0
SEP. 11 2003
510(k) Summary Medtronic In-Line Surgical Leads for Neurostimulation (as required by 21 CFR 807.92)
Submitter Information A.
| Submitter's Name: | Medtronic Neurological |
|---|---|
| Address: | 710 Medtronic Parkway NE |
| Minneapolis, Minnesota 55432.5604 U.S.A. | |
| Telephone Number: | 763.505.1465 |
| Contact Person: | Lucy Tan |
| Date Submission Prepared: | August 19, 2003 |
| B. Device Information | |
| Device Trade Name: | In-Line Surgical Leads for Neurostimulation |
| Common or usual Name: | Spinal Cord Stimulation Lead |
| Peripheral Nerve Stimulation Lead | |
| Classification Name: | Spinal Cord Stimulators (21 CFR Part 882.5880) |
| Peripheral Nerve Stimulators (21 CFR Part | |
| 882.5870) | |
| Classification Code: | GZB - Spinal Cord Stimulators |
| GZF - Peripheral Nerve Stimulators | |
| Predicate Device: | Resume II 3587A – K904507 |
| Resume TL 3986 - K904507 | |
| SymMix 3982 - K913993 | |
| On-Point - K920567 | |
| Device Description: | Quadripolar implantable neurostimulation surgical |
| leads with in-line connector. | |
| Indications for Use: | Resume II Model 3587A and Resume TL Model |
| 3986A are indicated for Spinal Cord Stimulation | |
| and Peripheral Nerve Stimulation to aid in the | |
| management of chronic intractable pain of the trunk | |
| and/or limbs. The peripheral nerve stimulators are | |
| used to stimulate electrically a peripheral nerve in | |
| patients to relieve severe intractable pain. |
On-Point Model 3987A is indicated for Peripheral
Nerve Stimulation to aid in the management of |
"မ
1
chronic intractable pain of the trunk and/or limbs. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.
SymMix Model 3982A is indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs.
Comparison of Required Technological Characteristics C.
The technological characteristics of the proposed ILS leads for neurostimulation are substantially equivalent to the noted predicate devices.
Performance Data D.
Performance data that supports the safety and effectiveness of the ILS leads for neurostimulation are included in this 510(k) premarket notification.
E. Conclusion
Medtronic neurostimulation ILS leads (Resume II 3587A, Resume TL 3986A, SymMix 3982A, and On-Point 3987A) are substantially equivalent to the noted predicate devices based on the similarities of technological characteristics, the identical indications for use and the results of the testing.
2
Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo contains the symbol of the Department of Health and Human Services, which is an abstract representation of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.
Public Health Service
SEP 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lucy Tan, RAC Senior Regulatory Affairs Specialist Medtronic, Inc. 710 Medtronic Parkway Minneapolis, Minnesota 55432
Re: K032561
Trade/Device Name: Resume II Model 3587A Regulation Number: 21 CFR 882.5880 and 21 CFR 882.5870 Regulation Name: Implanted spinal cord stimulator for pain relief and Implanted peripheral nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZB and GZF
Trade/Device Name: Resume TL Model 3986A Regulation Number: 21 CFR 882.5880 and 21 CFR 882.5870 Regulation Name: Implanted spinal cord stimulator for pain relief and Implanted peripheral nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZB and GZF
Trade/Device Name: On-Point Model 3987A Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted peripheral nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZF
Trade/Device Name: SymMix Model 3982A Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted spinal cord stimulator for pain relief Regulatory Class: Class II Product Code: GZB
Dated: August 19, 2003 Received: August 20, 2003
Dear Ms. Tan:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
3
Page 2 - Ms. Lucy Tan, RAC
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Page 1
510(k) Number (if known): K032561
| Device Name: | Resume II In-Line Surgical Lead |
|---|---|
| Resume TL In-Line Surgical Lead | |
| SymMix In-Line Surgical Lead | |
| On-Point In-Line Surgical Lead |
Indications for Use:
Resume II Model 3587A and Resume TL Model 3986A are indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs. They are also indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.
On-Point Model 3987A is indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.
SymMix Model 3982A is indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
OR
510(k) Number K03256/